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  • DUBLIN 2
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  • Job reference number:15276015
  • Client ID:RI/AM15961
  • Posted on:13-SEP-2017
  • Location:WORLDWIDE
  • Job type:PERMANENT

LEAD AUDITOR / TECHNICAL EXPERT - Medical Devices, for roles in USA.

Key Responsibilities & Tasks

• Conduct Registration, Surveillance and Re-certification activities at client facilities to assess their conformity to the related management system standard, and regulatory requirements
• Conduct the above audits and prepare the associated pre- and post-audit documentation in accordance with all organisational procedures
• Conduct site file Technical Reviews of audit documentation to support in granting and amending clients' QMS certifications
• Conduct Internal Audits of independent areas of the organisation's Quality Management System
• Perform technical reviews of product technical documentation to determine compliance with applicable standards and regulations, and to ensure safety and performance
• Communicate with assigned clients and organisation staff to ensure efficient audit planning and timely resolution of questions and non-conformities
• Stay abreast of technology and regulatory trends affecting certification
• Promote the Certification/Inspection service through the dissemination of information by correspondence, lectures and publications or otherwise as the opportunity arise.
• Respond to technical enquiries and responsible for timely communication and support to clients, administrative staff and Medical Device team members
• Maintain strict confidentiality of matters relating to client work at all times
• Undertake travel throughout the US and internationally, to evaluate applications for Certification and Registration Schemes

Interested applicants should have:

• Bachelor’s Degree or equivalent scientific, technical and/or vocational training and experience in a relevant field such as medicine, pharmacy, engineering or other relevant science

Minimum of four years’ experience working in the medical device industry ; OR minimum of one year relevant industry experience with an Advanced Degree (e.g. Masters of Science, PhD, etc.)
• Knowledge of the Quality Management Systems related to Medical Devices
• Strong understanding of international regulatory requirements for Medical Devices
• Understanding and working knowledge of International Standards for medical devices, such as ISO, EN, IEC, ASTM, ANSI and/or AAMI
• Training or Qualification as QMS Auditor or QMS Lead Auditor under ISO13485, with preference given to Notified Body, CMDCAS, MDSAP experience
• Ability to analyze data and write clear, concise summary reports
• Good interpersonal skills, with the ability to relate to people at all levels within and outside the organisation
• Ability to work on own initiative and to work as part of a team
• On the basis of requirements and/or evidence, being able to take and hold positions with clients in a professional and courteous manner
• Presentation skills as necessary to provide clear communications to clients

This job originally appeared on RecruitIreland.com